Senior Biomarker Data Specialist

Clinical Development Operations US Field Based


Description

Summary: 

The Senior Biomarker Data Specialist (Sr. BDS) is responsible for independent oversight of clinical specimens and associated laboratory data collected throughout the life of a clinical trial, including safety labs, PK, biomarkers, tumor samples, etc. The Sr. BDS independently drives lab-related aspects of a clinical trial by collaborating with cross-functional teams to plan, develop and execute operational objectives. The Sr. BDS manages clinical specimen plans and associated tools in support of study startup/amendments, sample tracking and handling, external lab data transfers, and reconciliation of vendor data with clinical data. They lead operational plans and timelines related to data deliverables and locks. Additionally, they play an integral role in laboratory vendor evaluations and startup, development and review of study protocols and scientific oversight of analytical laboratories. The Sr. BDS has a robust understanding of clinical laboratory and biomarker testing typical in an oncology setting and is adept at handling specimens and lab data. They have in-depth knowledge of FDA regulations, clinical data management best practices, and general industry standards and will lead departmental infrastructure development.  

Responsibilities: 

  • Independently oversee laboratory specimen and data management procedures  
  • Utilize templates and standard guidelines to initiate documents, but demonstrate critical thinking, alignment-building and discretion to tailor documents to study needs  
  • Independently manage multiple project streams, each with their own timelines, objectives and deliverables. Internal stakeholders may include Clinical Pharmacologists, Biomarker & Bioinformatics scientists, Clinical Project Managers and others. External stakeholders may include vendor representatives such as Project Managers, Data Analysts and others  
  • Manage and conduct data cleaning activities for vendor data reconciliation. Gather cross functional input to drive creation of custom data review plans. Evaluate options and exercise discretion to choose efficient and effective issues resolution paths  
  • Manage and resolve complex problems that require in depth evaluation, while balancing multiple stakeholders and priorities as well as sourcing appropriate resources  
  • Work with internal and external stakeholders to coordinate specimen testing in accordance with study plans and timelines  
  • Maintain an integrated tracking and inventory log of all specimens collected during a clinical trial, interpret data and share metrics with stakeholders  
  • Lead and oversee vendor collaborations to efficiently drive projects forward, overcome challenges, establish best practices and ensure quality data  
  • Function as sole independent unblinded Biomarker Data Specialist to review and reconcile lab data on blinded trials  
  • Create detailed specifications for tabular and unstructured data by working with various stakeholders to ensure appropriate metadata variables and fit-for-purpose data structure that meet end user needs  
  • Provide expert feedback on contracts and study documents to ensure alignment with stakeholders’ needs, internal processes and vendor capabilities. Facilitate discussions and gain alignment as needed  
  • Run SAS programs, review SAS logs, and generate output. Program SAS Non System Edit Checks (NSECs) and/or SAS Data Listings as appropriate for SAS skill level. Mentor less proficient SAS users as appropriate  
  • Assist in training and mentoring Biomarker Data Specialists I/II and/or contract staff; utilize experience and leadership skills to provide guidance to other team members, may supervise support staff  
  • Spearhead processes and infrastructure projects for managing external data, including creating templates, flow charts, wikis and other guidance documentation  
  • Innovate and lead process/systems improvement projects 

Qualifications: 

  • Years of experience: 5 – 8 years  
  • Demonstrated leadership, project management, risk assessment, decision-making and timeline management skills  
  • Experience working or collaborating on clinical research projects; exposure to the clinical drug development field  
  • Clinical testing lab and/or vendor oversight experience, previous sample tracking and handling experience  
  • Laboratory background and strong knowledge of commonly tested biomarkers in the oncology setting, latest and advanced analytical tools and assays  
  • Prior experience authoring specifications and implementing new processes  
  • Proficiency with data sets and Excel, strong understanding of data relationships and metadata  
  • Technologically savvy; quickly picks-up on new information, standards, regulations, tools, methods or software as it relates to position and profession  
  • Detail oriented; performs quality and accurate work without oversight  
  • Excellent written/verbal communication skills  
  • Interpersonal skills; facilitates collaboration, is a team player and is cooperative, builds constructive and effective relationships, is approachable, communicates effectively  
  • Flexible, easily adapts to change, and is energized by challenges and problem solving  
  • Demonstrated ability to learn new skills and knowledge quickly, able to offer new ideas but also willing to adapt style to existing process as appropriate 

Preferred Qualifications: 

  • Software programming or systems development experience  
  • Previous LIMS (Laboratory Information Management System) experience  
  • Previous Electronic Data Capture (EDC) experience  
  • Understanding of and abreast in FDA regulations, drug development industry, ICH GCP guidelines, SDTM, CDISC, database development and UAT  
  • Oncology experience 

Education: 

  • BA/BS in relevant field; years of experience may substitute for education 

As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com. 

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. 

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